An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216725
Company: MANKIND PHARMA

Products on ANDA 216725

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	AN	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216725

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216725

TOBRAMYCIN

SOLUTION;INHALATION; 300MG/4ML
TE Code = AN

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETHKIS	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	Yes	AN	201820	CHIESI
TOBRAMYCIN	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	No	AN	216725	MANKIND PHARMA
TOBRAMYCIN	TOBRAMYCIN	300MG/4ML	SOLUTION;INHALATION	Prescription	No	AN	210915	TEVA PHARMS USA

Top